A&P CREATIONS — Class I: X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 77080752
A&P CREATIONS has initiated a Class I recall for X10 Natural Enhancement Supplement due to the presence of undeclared Sildenafil and Tadalafil. The recall involves 0.5 fl oz sachets distributed in 7-count boxes under UPC 7708075247094.
This recall affects A&P CREATIONS, its distributors (Natur Fuel), the manufacturer FutuPro S.A.S., and quality/regulatory personnel involved in the dietary supplement supply chain.
A Class I designation indicates the FDA's assessment of a reasonable probability that exposure to the product will cause serious adverse health consequences or death. The presence of undeclared phosphodiesterase (PDE-5) inhibitors in products marketed as natural supplements represents a significant regulatory failure in ingredient verification and cGMP compliance, potentially leading to severe enforcement actions against the distributor and manufacturer.
Immediately quarantine any remaining inventory of the affected UPC; initiate or verify supplier audit protocols for contract manufacturers to ensure raw material and finished product testing for undeclared pharmaceutical ingredients.
Class I. Reason: Product contains undeclared Sildenafil and Tadalafil.. Product: X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094, Manufactured by FutuPro S.A.S., Colombian Industry; Distributed by Natur Fuel, 2725 Armstrong Avenue, Clermont, FL 34714.. Firm: A&P CREATIONS (Clermont FL United States). Status: Ongoing.
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